Quantum Leap Healthcare Collaborative (QLHC) has concluded the enrolment in the icatibant arm of the I-SPY COVID Trial testing various agents in treating critically ill patients.
The latest development comes after the Data Monitoring Committee recommended concluding the icatibant arm on enrolling 95 patients and the agent meeting the predefined futility criterion.
In the trial, subjects received a 30mg subcutaneous dose of icatibant plus backbone therapy (dexamethasone and remdesivir) every eight hours for six days and followed up for 28 days.
According to the data, the addition of icatibant to backbone therapy showed a reduced chance of causing any impact on time to recovery or mortality.
The phase II, open-label, adaptive platform trial is being carried out in these patients who are receiving high flow oxygen or mechanical ventilation.
This trial is designed to quickly monitor agents that demonstrate potential in lowering the time to recovery (defined as a reduction in oxygen need) by around 50% or risk of mortality in critically ill Covid-19 patients.
A regimen will be recommended to be discontinued from the trial for futility if the treatment has 90+% of chances in providing a 50% benefit versus standard treatment.
University of California, San Francisco medicine professor and co-principal investigator and chaperone of icatibant arm of the trial Dr Kathleen Liu said: “We chose icatibant because of its track record of safety and efficacy in reducing the swelling associated with acute attacks of hereditary angioedema and that its mechanism of action involving bradykinin signalling has been linked to the biology of acute respiratory distress syndrome (ARDS) in Covid-19 patients.
“Icatibant did not impact patients critically ill with Covid-19 when compared to those receiving backbone therapy alone.”
The company also concluded the razuprotafib and apremilast arms.
The I-SPY COVID Trial is currently progressing with additional agents in 22 sites, as well as leaders in pulmonary and critical care centres from around the US.